BEUDAMED
    FDA Adverse Event Other Summary report: N

    BELOS DR-T

    MDR report key: 5340556 · Received December 20, 2005

    Report

    Report Number
    1028232-2005-00209
    Event Type
    Other
    Date Received
    December 20, 2005
    Date of Event
    June 28, 2005
    Report Date
    June 28, 2005
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR - THE ICD UNDERWENT A STATUS INTERROGATION DURING WHICH THE CLINICAL COMPLAINT WAS CONFIRMED. A TELEMETRY CONNECTION COULD NOT BE ESTABLISHED. THE ICD WAS OPENED. THE BATTERY WAS DISCHARGED, BUT NOT DEFECTIVE. THE TEST OF THE ELECTRONIC MODULE SHOWED A DAMAGED FINAL STAGE FOR SHOCK. AS A CONSEQUENCE, THE CURRENT CONSUMPTION OF THE ELECTRONIC MODULE WAS PERMANENTLY INCREASED, WHICH LEAD TO THE BATTERY DISCHARGE. THE ADDITIONAL ANALYSIS SHOWED THAT THE FINAL STAGE FOR SHOCK WAS DAMAGED DURING SHOCK DELIVERY. WE WILL HAVE TO CONSIDER THE SITUATION THAT A DEFECTIVE LEAD INSULATION BETWEEN HV-1 AND HV-2 LEAD TO SHOCK DELIVERY IN A SHOCK PATH WITH LOW OHM VALUES. THE FINAL STAGE FOR SHOCK IS PROTECTED AGAINST DAMAGES OF SHOCK DELIVERY FROM A SHOCK PATH WITH LOW OHM VALUES. HOWEVER, DUE TO HIGH SHOCK ENERGIES, DAMAGES CANNOT BE GENERALLY RULED OUT.

    Description of Event or Problem · 1

    OUS MDR. IMPLANT CANNOT BE INTERROGATED, NO PM FUNCTIONALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    0 BELOS DR-T ICD NIK BIOTRONIK GMBH AND CO. 338171

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention